Israel Patent Opposition Suspended Pending Examination of a Divisional Application

October 22, 2014

boehringer       procrastinate

In another Patent Opposition, Teva Pharmaceutical Industries opposed Israel Patent Number 195030 titled “DPP IV INHIBITOR FORMULATIONS” to Boehringer Ingelheim International GMBH.

The patent published for opposition purposes on 30 September 2013 and an opposition was filed on 29 December 2013 and there is a pending Divisional application – IL 212841.

On 22 January 2014, the Opposer requested to suspend the Opposition process under Israel Patent Office Circular 020/2012 which allows suspension of Opposition processes whilst related applications are examined, provided that a detailed request to do is filed. The Opposer considers the claimed subject matter of the two cases as very similar. Although there are differences, these are minor. The Applicant accepts the similarity but does not consider this as in and of itself being a prima facie justification for suspending examination, and that at best this is grounds for a detailed request. Until such a request is filed, there is no basis to suspend the Opposition proceedings (which leaves the allowed patent in suspense, such that it cannot be enforced).

In ruling on this matter, the Commissioner (who drafted the original Circular) ruled that the existence of the Divisional Application was not, of itself, sufficient grounds to suspend the opposition. It is, in his opinion, too early to identify the claimed invention. However, under Section 24, the specification of a Divisional Application will invariably be very similar to that of the Parent Application, and this is the basis of the Opposer’s assumption that similar issues will arise in the Divisional application if it is allowed, and so suspension until that time to hear both cases together makes sense. The consideration as to whether or not to suspend the opposition is efficiency and the case is similar to other cases where an ongoing proceeding is suspended until another is decided. There is a Supreme Court precedent that relates to this issue: Appeal by authorization 3765/01 “HaPhoenix HaYisralei Insurance Company vs. Alexander Kaplan et al. (28 Jan 2002), where, in paragraph 3, it is stated that in the name of efficiency courts have the discretion to combine hearings, even where the parties are different. In the Opposition to IL 82910 Unipharm vs. Anktielofaget Hassle (1996) this principle is applied to patent cases; justification being Reg. 520 of the Civil Law Procedure. The purpose of suspension is thus to allow the apparently similar / related cases to be combined. The Opposer is correct that the currently pending claims of the Divisional Application are somewhat similar to those in the opposed patent.

It is important to consider the rights of third parties and other considerations than simply efficiency of combining from the perspective of the patent office. In this case, it is likely that the Opposer (TEVA) will oppose the divisional application, should it issue. In conclusion, the Commissioner agreed  to suspend the Opposition for 18 months and to then reconsider in light of developments concerning the divisional application.

COMMENT

There are certainly similarities between court cases and oppositions. There are, however, some pertinent differences. One does not suspend a court case pending a possible filing of a related case, only to wait for an ongoing case to issue.

Oppositions are complicated proceedings that take time. Indeed, a primary purpose of filing them is to prevent a patent from being enforceable. Suspending an opposition to claims that have been examined and allowed on the basis that some additional claims may eventually be allowed seems to be a punishment to the Applicant. It seems to me that the opposition to the allowed patent should be allowed to proceed, with statements in the Opposition filed by both the Applicant and the Opposer serving as estoppel in possible future oppositions of the divisional. Factual issues that are determined should be binding on the future hearing. If and when the divisional patent is allowed, and an opposition is filed, overlapping grounds could be co-joined to this opposition and new grounds could be heard separately. I therefore consider this ruling to be wrong.

I have thus somewhat surprised myself by coming out in favour of the pharma Applicant and against the generic Opposer.  I console myself in that in this case the issue is one of legal principle and not one of novelty or inventiveness / obviousness. I am against evergreening, but I am also against misuse of the patent opposition system to prevent patents from issuing by uneccessary time-wasting.  Comments, anyone?


IL 136294 Pharmacia and Upjohn Successfully Opposed by Teva

October 20, 2014

Pharmacia

Pharmacia and Upjohn filed IL 136294, titled “Use of tolterodine, its 5-hydroxymethyl metabolite or racemate thereof in the preparation of medicaments for treating unstable or overactive urinary bladder”. On 6 May 2004, Teva filed an opposition.

The Application was a national phase entry of PCT/SE99/01463 which claimed priority from SE 9802864-0 and SE 9802871-4 filed on 27 August and 11 November 1998 respectively.

On 11 June 2003, a Divisional Application (IL 156414) was filed. Following the publication of patent office circular M.N. 23, the Opposition was frozen pending Examination of the Divisional Application. On 20 March 2006 the Divisional Application was abandoned and the file closed, and the Opposition procedure in the parent application was restarted.

On 19 June 2006, Teva submitted a detailed Opposition and Upjohn filed a counterclaim on 13 November 2006. Following submission of evidence, counter-evidence and responses, a hearing was held on 1 and 2 April 2009 before then Commissioner, Dr Meir Noam.

After the hearing, the parties submitted their concluding remarks between 21 April 2010 and 26 January 2012, after Dr Noam’s term of office finished. The Present Commissioner, Asa Kling, ruled on the case under regulation 202a, on the basis of the material in the file.

According to the Commissioner, the Opposition is two-fold. The Opposers argue that there is no inventive step in contravention to Section 5 of the Patent Law, and that the claimed invention is a method of treatment of Man and thus contrary to Section 7.

The Opposer, Teva, submitted their evidence via an opinion of Professor Danon. The applicant, Upjohn, submitted their evidence via an Opinion from Professor Abrams and a statement of Dr Wood. Teva submitted counter-claims via a second affidavit of Prof. Danon and an opinion by Professor Mor.

The patent relates to a treatment for sufferers of unstable or overactive urinary bladder. The problem is caused by a lack of control of smooth muscles around the bladder that receive electronic stimulation. The standard treatment at the time of filing involved desensitizing the nerves with tolterodine or oxybotynin. Both desensitizers had various adverse side effects including dryness of mouth. In minimizing this side effect, tolterodine was preferable to oxybotynin. Tolterodine is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine, where R indicates the Right handed enantiomer, and S, the sinister, or left handed enantiomer which does not work. The two desensitizers and the enantiomers are discussed in the specification.

The Application as allowed had 17 claims, of which claims 1, 8, 16 and 17 are independent.

Claim 1 is as follows:

  1. Use of tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, in a pharmaceutically effective amount thereof through a controlled release formulation capable of maintaining a substantially constant serum level of the active moiety or moieties for at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h, for the manufacture of a therapeutical formulation for treating unstable or overactive urinary bladder, substantially as described in the specification.

Claim 16 is similar, but includes the following limiting feature:

… with reduced undesirable side effects and with no reduction in the efficiency of the tolterodine compound…

Claim 8 is as follows:

  1. A pharmaceutical formulation containing tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, which formulation when administered to patient provides controlled release of said tolterodine its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, such that a substantially constant serum level of the active moiety or moieties is maintained foe at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h.

Claim 17 follows claim 8 , but includes the following limiting feature:

…for efficacious therapy with reduced undesirable side effects…

In order to ascertain inventive step or non-obviousness, the standard is that of a person of the art. Professor Danon and Dr Wood are pharmacologists. Professor Mor and Professor Abrams are urologists. Both sides argued whether in this case the person of the art to determine non-obviousness would need to be would need to be a pharmacologist, a urologist or a team including both skills. Accroding tot he Commissioner, this question may be answered by reference to Former Supreme Court President Shamgar in 345/87 Hughes Aircraft vs. State of Israel P.D. 44(4) 45 (1990) as including a person or team with knowledge of relevant subject matter but no creative ability. The Opposer (Teva) considers the person of the art to be a pharmacologist specializing in the relationship between active ingredients and the human body. The Applicant considers that persons of the art may be a team including pharmacologists and doctors of the relevant speciality, which in this case includes urologists.

The Applicants distinguish between the pharmacological and the pharmo-kinetical aspects of the invention, which in their words, are directed to a pharmacologist or formulator, and the medicinal aspects of the drug which are directed to a urologist. Professor Abram’s opinion follows this distinction.

“Obviously, once the pharmaceutical invention is made… pharmacokinetic and pharmacologic considerations become relevant. However, unless the pharmaceutical invention is made first, the pharmacologist is not a relevant person.”

According to the Applicant, the motivation to develop a drug is based on medical needs and so the application is primarily directed to the urologist, and other professionals, such as pharmacologists are consulted only once the drug is being developed to answer a specific medical need.

The Opposer considers that the medical need is the problem to be solved, and the person to be consulted to solve the problem is the person the art. Support for this position is found in “Patents for Inventions” by T.A. Blanco White, 5th Edition page 90:

“In principle, it would seem clear that the proper people to think of in judging obviousness are those who would in practice be called upon to solve problems of the sort concerned.”

Furthermore, the Expert for the Applicant Professor Abrams himself stated that the urologist might identify the clinical condition and would describe it to the pharmacologist, which strengthens the position that the person of the art is, in fact, the pharmacologist.

The Commissioner ruled that the person of the art is indeed the pharmacologist, although the urologist might well initiate the process of developing a drug.

Support for this was found in Alza Corporation vs. Mylan, a US ruling concerning urine leakage, where it was stated that:

“In their post-trial memoranda, the parties do not directly dispute the level of ordinary skill in the art at the time of the ‘355 patent’s filing. Thus, based on the testimony of Dr. Amidon and Dr. Peppas, the Court finds that a person of ordinary skill in the art has either an advanced degree in pharmacy, biology, chemistry or chemical engineering and has at least two years of experience with controlled-release drug technologies, or possesses a bachelor’s degree in one (or more) of the same fields and has at least five years of experience with controlled-release drug technologies.”

Consequently, the Commissioner ruled that whilst a urologist could be included in the team, the persons of the art defining obvious would include a pharmacologist.

As far as inventive step is concerned, the issue in question boils down to whether something would have been considered obvious by a pharmacologist, or by a team consisting of a pharmacologist and a urologist.

Both sides agreed that:

  1. As of the priority date both tolterodine or oxybotynin in instant release form were being used to treat unsteady or over-active bladders. Furthermore, oxybotynin was also being used in a controlled release form.
  2. It was understood that oxybotynin caused more serious side effects of dry-mouth and thus tolterodine was the preferred treatment.
  3. Dry mouth symptoms of tolterodine were most prevalent when tolterodine was at its highest concentration in the blood.
  4. It was already established that tolterodine had a positive effect on unsteady or over-active bladders after its effect on saliva forming and the symptoms of dry-mouth had disappeared.
  5. Moving from instant release to slow release formulations may not be successful for treatment of unsteady or over-active bladders and the efficacy required clinical trials.
  6. The Applicants considered that the minimal problems of dry mouth associated with tolterodine in quick release form were such that there was no motivation to develop a slow release version of the drug. Furthermore, slow release Oxybotynin did not have less slide effects than the quick release version so the urologist would be likely to conclude that slow release tolterodine would behave in a similar fashion.

Finally, according to the Applicants, it transpires that the slow release tolderine is actually more effective. This is not supported by the specification and is first raised as a consideration in the Applicant’s statement of claims. There is no evidence that Applicant was previously aware of this point.

The Applicant does not claim that this fact is relevant to the issue of inventiveness, but the commissioner nevertheless emphasizes that such post filing revelations are irrelevant to the issue of inventive step (non-obviousness) and the Applicant can’t turn the clock back. There has to be an inventive step at the time of the priority filing (albeit, possibly one discovered by accident).

The parties now debated a very interesting point. Regardless of the surprising improvement of the not particularly serious dry mouth side effect, according to Teva there was a drive towards creating a slow release version of the treatment since this would enable taking a pill once a day instead of twice a day. They consider this fact self-evident and not requiring scientific proof.

Upjohn countered that this advantage of merely reducing the dosing frequency would not have warranted a switch to a controlled release treatment. They considered that the frequency of dosage was a minor issue for chronically ill patients and thus with the anticipation of increased side-effects, the drug developer would have no drive to develop a controlled release version. Citing Goldstein and Kalman:

“Certainly the oral ingestion of a drug 3 or 4 times daily presents no hardship to the patient; the substitution of a single daily dose of a sustained-release preparation would not be warranted unless some advantage other than convenience had been demonstrated.”

The Commissioner rejected this argument, preferring Glaxo group LTD’s Patent [2004] R. P. C. 843:

“That salmeterol would be the obvious substitution for salbutamol follows from the most basic consideration, that a drug that only needs to be taken twice a day will encourage compliance.”

And

“…the patent must be invalid, because I consider that the problem of compliance has, on the evidence, always been a problem.”

The Opposer considered that despite possible problems in achieving, it is obvious to try to reduce the dosage frequency, and thus a mere change in dosage frequency achieved by a coating is not inventive.

The Applicant countered that the development of a slow-release version warranted a patent since there were many cases where controlled release was less than successful, and they brought three examples of this.

The Opposer showed why the three examples were all exceptions to the rule and the commissioner felt that the onus was on the Applicant to show why this instance should be considered inventive.

Both parties accepted that tolterodine was preferable because of its lesser severe side effect of dry mouth. The Applicant considered that this being reduced further by controlled release dosages was patentable.

“According to the present invention it is now surprisingly been found that contrary to the case of oxybutynin, the substantial elimination of peak serum levels of tolterodine and its active metabolite through controlled release of tolterodine for an extended period of time, such as through a once-daily administration form, while maintaining the desired effect on the bladder, indeed gives a significant reduction of the (already low) side effects, particularly dry mouth, compared with those obtained for the same total dosage of immediate release tablets over same period.”

The commissioner noted that Upjohn had stated that this was a surprising discovery, but that they had not actually explained why this was the case. He noted that the Opposers reasoned that if regular tolterodine has lower dry mouth side effects than oxybutynin, this would remain the case with quick release versions.

The commissioner felt that the Applicants had not explained why, despite the fact that occasionally slow-release preparations might have unwarranted side effects or efficacy issues, it would not have been obvious to try to reduce the frequency of the dosage to once a day only.

Furthermore, earlier patent WO098/03067 notes that the S-enantiomer is preferable to the R-enantiomer and suggests a more frequent dosage or a controlled release. On this point, the Applicant tried to argue that since the current application relates to the S-enantiomer only, the earlier patent was irrelevant. Furthermore, the earlier patent suggests multiple frequent dosages which teaches away from the present invention. The commissioner did not find these arguments persuasive and still considered it would be have been obvious to try.

The Opposer considered the experimental evidence as totally anticipated by persons of the art and that there was nothing surprising in it.

The cut and thrust of the parties is reported in depth, but the general tendency of the Commissioner is to uphold the ruling in IL109059 F. Hoffmann-La Roche AG vs. AGIS Industries (1983) LTD from 17.10.2004 that it would have been obvious -to-try.

“First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile.” (Brugger v. Medic-Aid Ltd., [1996] R.P.C 635 at 661)

“… Whether the subject matter was obvious may depend upon whether it was obvious to try in the circumstances of that particular case and in those circumstances it will be necessary to take into account the expectation of achieving a good result. But that does not mean that in every case the decision whether a claimed invention was obvious can be determined by deciding whether there was reasonable expectation that a person might get a good result from trying a particular avenue research. Each case depends upon the invention and the surrounding facts. No formula should be substituted for the words of the statute. In every case the court has to weight up the evidence and decide whether the invention was obvious. This is the statutory task.” (Norton Healthcare v. Beecham Group Plc, CA, (1997)) ([2004] R.P.C. 43 at para 42)

Consequently, the claimed invention was found to be obvious and the Opposition was accepted.

Opposition by Teva to IL 136294 Pharmacia and Upjohn, Assa Kling, 30 September 2014.

COMMENTS

I am neither a pharmacologist nor an urologist, (although I do enjoy taking the $%*& against poor decisions occasionally). It is established that the standard of inventiveness of obvious to try. Both sides accept (at least tacitly) that when taking tolterodine, once the problem of dry mouth is addressed, it would be obvious to try a slow release formulation, so the solution is fairly obvious. The question remains whether identification of the problem as a problem is worthy of a patent. Here the pro-pharma lobby will stand on their chairs and wave banners that of course this is patentable, whereas the generic side of the industry will have serious reservations. This may not just be a question of who pays one’s bills. It is at least possible that attorneys and scientists with different philosophies get drawn to the different market sectors that reflect their look on life.

Having a general background in chemistry but no background in pharmacology I tend to side with the generic industry. I suspect that most impartial patent attorneys with backgrounds in computing or engineering would find the Applicant’s arguments tortuous and unconvincing.

One question not addressed is why they chose to try to develop a controlled release version if there was no a priori assumption of it being preferable? (If the answer is ever-greening, is this acceptable, or is it obvious to try to keep a drug patent protected indefinitely?

Arguably the standard of obvious to try is to high, but it is the standard that Dr Meir Noam, the previous commissioner set. He was a chemist.

The present commissioner, Asa Kling is an aeronautical engineer.  He is no more a person of the art than I am. Nevertheless, his position as commissioner requires him to decide who the person of the art is, what is the standard for inventiveness and particularly whether identifying the issue of this side effect is in and of itself an inventive step. Really the issue is one of policy. The drug development industry will no doubt cry out that the Israeli standard is too high, whilst the generic industry will be more supportive of this ruling. If this ruling is appealed to the courts, the Commissioner’s determination will be scrutinized.

 


Astrologist Successfully Sued for Copyright Infringement of New Card Designs – She didn’t see it coming

October 20, 2014

Astrological cards

Zur-Klein is  an astrologist. Tal Rinkov is an artist who created 37 cards for the Astrologist in accordance with an agreement between them which, inter alia, related to the copyright ownership.  (Ms Rinkov was also the kindergarten teacher of Ms Zur Klein’s daughter, which is how they met (some would say it was fate).

Ms Zur-Klein ordered 40 card designs for a payment  of 5000 Shekels.  The cards were to be mass-produced and distributed with an instruction manual and a teaching movie. The parties entered an agreement on 5 September 2014 that established several principles:

  1. The original artwork and the copyright of the artwork was to remain that of the artist.
  2. The artist would not be entitled to royalties for packs of cards and other goods itemized in the agreement
  3. The Astrologist would only be entitled to use the images on specific listed items
  4. All internet images  would be reproduced at a low resolution only
  5. All pictures would carry Ms Rinkov,’s signature, her name, website and contact details

Ms Rinkov was hospitalized in November of that year and only delivered 37 designs, and the last three were completed by another artist. (For reasons not apparent, the medium missed this eventuality). The images were transferred to a graphic artist who made various graphical changes to make the images more suitable for printing.

After various commercial entities expressed interest in the images, Ms Zur-Klein contacted Ms Rinkov to try to negotiate a transfer of copyright but due to a difference of opinion, no agreement to transfer the copyright issued.

Ms Zur-Klein  publicized the images in various internet sites including her own and other people’s, in her blog, Facebook page and elsewhere.  In all reproductions of the cards on the Internet, the artist’s signature appeared, but her name and contact details were not given. Indeed, on some websites, Ms Zur-Klein presented herself as the creator of the card (the term יוצרת הקלפים is used, which is both creator and manufacturer so the term is somewhat ambiguous). Furthermore, Ms Zur-Klein allowed other astrologists to use the designs without giving any credit to Ms Rinkov. There was also a newspaper article featuringMs Zur-Klein that was illustrated with one of the card designs that was also not credited.

On 6 June 2012, Ms Rinkov sent Ms Zur Klein a Cease & Desist letter.

The basis of the ensuing court case was the agreement signed by the parties. It is translated below:

Tal prepares for Carni 39 pictures, which together with the picture already executed, provides a set of 40 pictures for cards and other purposes – payment 5000 Shekels.

Apart from the payment for the work, there will be no other royalties for selling packs of cards, books, CDs and other astrological items depicting the images of Tal Rinkov.

The astrological products that Karni is allowed to use the pictures on are: packs of cards, books, audio CDs, video for watching, a banner for a website, business cards and other articles on authorization from the creator. Karni may not manufacture or distribute artistic works such as pictures, mugs, key-rings and the like.

All material displayed on the Internet are at low pixel count.

The name, website and contact details of Tal Rinkov will appear on all products, including future products.

The pictures on the cards and elsewhere will include the artist’s signature.

The original artwork and copyright remains the exclusive property of Tal Rinkov.

Pictures and associated artistic products (that are not astrological) will be produced and distributed exclusively by Tal Rinkov.

Any deal that Karni creates for Tal will generate a 20% commission for Karni.

When Tal sells a product (book, CD, cards and the like) she will profit 20%. Tal will receive a present of a pack of cards.

 According to the plaintiff, the defendant wrote the contract after the negotiations. The defendant claims, however, that the contract was the plaintiff’s idea, and that the plaintiff had written most of the clauses to the detriment of the defendant, such as her not getting benefit from sale of the cards. However, the defendant agreed that she had printed out the agreement.

The defendant claimed that she was entitled to the status of co-creator in the cards as although Ms Rinkov executed the artwork, it was to her, Ms Zur Klein’s specification regarding the symbolism, colors and charms. The plaintiff considered this a change of direction in the defence and objected to it on principle.  The judge ruled that the claim that the defendant hand guided the artist appears in clause 31 of the defence, but is more a factual than a legal defence and so she was willing to contemplate it. The plaintiff countered that Carni Zur-Klein had not, in fact, instructed her, but that she herself had researched the elements and colours.  Both sides supported their contentions with emails and other evidence. It does seem that the astrologer gave guidelines for the design, but these are by way of astrological knowledge rather than artistic input.

RULING

In this instance, Judge Lemelstrich  did not consider that under section 1 of the Copyright Law 2007, the two parties could be considered co-owners of a joint creation. Section 64 creates a rebuttable assumption that the artist is the creator and each card design was signed by Ms Ronkov as the artist.

Section 5 of the Copyright Law notes that the idea, way to implement and facts are not copyright protected, only the  artwork itself is. According to Section 35a of the Copyright Law, a work for hire is the property of the artist in the first instance, unless otherwise agreed implicitly or explicitly. In this instance, both the Copyright Law and the contract  support the artist as owner of the copyright.

In the packs of cards, Ms Rinkov is acknowledged as the artist and Ms Zur-Klein is credited as an astrologer.

The parties agree that Ms Zur-Klein conceived the project, but the copyright in the images remain the property of Ms Rinkov.

Ms Zur-Klein apparently sold some 80 packs at 190 Shekels a pack.

the main issue sees to be the internet reproductions which do not provide the details of Ms Zur-Klein.

The ruling now relates to various astrological websites. Since I find this subject matter morally, ethically and religiously abhorrent, I am refraining from reproducing the links.

The important thing is that Judge Lemelstrich considers that the artist’s moral and financial rights were compromised in numerous infringements in various websites and internet campaigns. That said, the pictures on the Internet were not reproduced at a quality to enable them to be printed and used as playing quality cards.

The changes to the designs for subsequent printing by a graphic artist under the direction of Ms Zur-Klein were minor. These were considered insufficient to create a change to the copyright, in that the original work could not be considered defaced or the artist’s moral rights compromised. Nor did the amendments constitute a copyright protectable creation.

Ms Rinkov claimed 100,000 Shekels in statutory damages for copyright infringement and a further 100,000 Shekels for moral rights infringement, particularly noting the long and arduous legal proceedings and the multiple infringements.

Judge Lemelstrich noted that despite entering a clear contractual relationship to the contrary, Ms Zur-Klein acted as if the creations were hers to do what she liked with. She ruled 35,000 Shekels damages for infringing the moral rights, 15000 Shekels for infringing the material rights and a further 5000 Shekels for an article published after the Cease and Desist letter.

Judge Lemelstrich of the Haifa District Court ruled a permanent injunction against Ms Zur-Klein, her delegates, substitutes and others from performing any action that violates the September 2011 agreement or other rights as per the statement of case.

Ms Zur Klein will compensate Ms Rinkov 55,000 Shekels for copyright infringement, an also will pay 15000 Shekels legal fees. The money will be paid within 30 days.

Civil Ruling 15824-10-12 Tal Rinkov vs. Carni Zur-Klein, Haifa Court before Judge R. Lemelstrich, Ruling 13 October 2014

 

 


Laches in Amending Claims During a Patent Opposition Procedure

October 19, 2014

Zometa

Novartis Pharma filed Israel Patent Number 153229 titled “Use of 1-Hydroxy – 2 – (Imadazol-1-YL) Ethane – 1, 1 – Diphosphonic Acid in the Preparation of A Medicament for the Treatment of Conditions of Abnormally Increased Bone Turnover”.

The Application was allowed and published for Opposition purposes on 24 July 2007, and Teva filed an opposition on 23 October 2007.

After the Opposer filed their statement of case, the Applicant requested to correct the specification. The Opposer did not oppose the amendment, but following it, filed an amended statement of case. During 2011 and 2012 the opposition proceeded. On 10 April 2014 the applicant requested to amend the specification a second time. The amendment consisted of canceling claim 1 and dependent claims 2-5 and amending claims 6 and 7. The basis for the amendment was that the UK court had voided the corresponding patent, allegedly on formalistic and technical grounds, but to forward the discussion in Israel, the Applicant wanted to  amend the specification by canceling these claims.

Teva opposed the amendment, arguing laches and inequitable behavior since it was years since they’d filed their statement of case. They further claimed that the UK court had voided the patent due to the priority date and not on formalistic grounds. The UK Court of First Instance had issued their ruling over a year earlier, and this should be taken into account when considering the request to amend the application. This consideration was strengthened by the Opposition to Israel Patent 324844 Gradstan LTD vs Bristol Myers Squibb (6 March 1979). Furthermore, the request to amend the claims was not supported by an affidavit, and this was further grounds for refusing the request.

Novartis counter-claimed that the Appeal to the UK Supreme Court had only issued on 10 July 2014 and therefore there were no laches or inequitable behavior. Furthermore, if an affidavit was required, the applicant would be happy to provide one.

Teva countered that the flaws requiring correction were stated in the statement of case and Novartis should have corrected their application at the first opportunity which was over four years earlier.

THE RULING

The main argument is whether there is a statute of limitations or laches for amending a specification after allowance and before grant. The Opposer cited a very old case from 1979 to argue that this couldn’t be allowed, whereas the applicant cited the more recent Opposition to IL 101537 Merck and Co. vs. Unipharm Inc. (30 April 2003).

The Deputy Commissioner noted that she had ruled on the grounds for post allowance amendments under Sections 29, 65 and 66 f the Law in Reva vs. Astellas Pharma and in Rafael vs. Elta, both from May 2014.

The ability to amend the claims provides an advantage to the applicant, but it also results in side skirmishes that hold up the issuance of the patent, to the advantage of the opposer and to the detriment of the applicant.

In this instance, the request to amend the claims comes after the submission of evidence, at the stage of the hearing. However, this was justified by the UK ruling only now being made final.

Nevertheless, the request could have been made some months ago and wasn’t. No explanation was given. Although the ongoing Opposition prevents a patent from issuing (and being enforceable), it also provides uncertainty to competitors and the awarding costs only partially mitigates this.

The Gradstan case was exceptional in that five years had passed from when the applicant knew that the specification should be amended and, according to the then commissioner (Yoel Tsur?) the proposed amendment did not achieve its purpose.

In Merck vs. Unipharm the then commissioner (presumably Dr Meir Noam) ruled that even where there is a delay, the applicant should be able to amend the specification unless there is inequitable behavior or the applicant had previously fought tooth and nail for the wider claim set.

The Applicant’s reason for the delay (pending final ruling in the UK) is prima facie justification to wait until now. Hence, the delay is a matter of months, not four years and awarding costs is a fair way to compensate the Opposer.

There is no argument that the amendment is one that narrows the scope of protection since claims 1-5 are canceled and claims 6 and 7 are also narrowed since they specify a range of doses for menopausal women and the amended ranges are within the original ranges. The amended claims are also both fully supported by the specification.

As to the requirement for an affidavit, Ms Bracha ruled that this is required to support a factual matter about which there is some dispute. In this matter, that is not the case. Both sides agree when the original UK ruling was and when the Appeal ruling made it final.

CONCLUSION

The requested amendment is allowed and will publish for third-party oppositions. Absent such oppositions, the Opposer may file a corrected statement of claims within one month. If he does not wish to correct the statement of claims, he should alert the patent office of this within that month, and a hearing will be scheduled to examine the evidence.

Since this is the second request to correct the application and was filed some months after it transpired that there was a need to amend the claims, the Deputy Commissioner ruled costs of 3000 Shekels and attorneys fees of 30,000 Shekels + VAT. Furthermore, should the Opposer choose to amend their statement of case and to correct their evidence, they will be entitled to further costs regardless of the ultimate outcome of the proceedings

COMMENT

The active ingredient seems to be Zoledronic acid and the drug in question appears to be Zometa®.

This ruling seems fair.

Refusing to allow a patent to be amended due to the request not being supported by an affidavit seems to me to be formalistic. I would not consider a problem with the priority date as merely formalistic though.


Calculation of costs re Israel Trademark Number 242574 for “OSIS”

October 19, 2014

OSIS

AG & Co. KGaA applied for Israel Trademark Number 242574 for “OSIS”

The mark was applied for perfumery goods, essential oils, cosmetics, preparations for treating, washing, dyeing, bleaching, styling and perming hair, soaps in Class 3, and for mechanical implements for body and beauty care (included in this class), sponges, brushes (except paint brushes), apparatus and receptacles for applying hair dyes in class 21.

Ein Gedi Cosmetics opposed the registration.  After several extensions, Henkel abandoned the mark. On 13 July 2014 Ein Gedi requested costs of 12,000 Shekels. On 18 August 2014, Henkel responded to the request for costs.

The Adjudicator of IP issues, Ms Shoshani-Caspi, accepted that in general, the party prevailing in a proceeding is entitled to costs. In this instance, the Applicant did not detail his requests for costs which therefore have to be considered as an estimate only.

In Bagatz 891/05 Tnuva vs. Department of Industry it is stated that to obtain real costs, the applicant should detail the basis of calculating legal fees, the amount of work, and whether it was actually paid. After this is done, the opposing party should explain why the requested costs are inappropriate.

furthermore, Section 69 of the Trademark Ordinance gives the Commissioner (or whoever rules on the case on his behalf) discretion to award costs considered realistic.

In this case, since there was no basis to award actual costs, the adjudicator considered the complexity of the case, the amount of work, the professionalism of the parties, equitable behavior of the parties and with reference to Regulation 46 of the Trademark Regulations 1940, whether the case could be avoided were the Opposer to provide the applicant with sufficient notice.

Apparently the Opposer had not contacted the Applicant before filing the Opposition, but the Applicant had filed three extensions, indicating that they were originally considering and intending to respond. This was not considered as sufficient indication of inequitable behavior though.

Taking into account the amount of work done and that the opposer had to request costs,the Arbitrator of intellectual Property Ms Shoshani-Caspi ruled costs of 3000 Shekels including VAT.

Ein Gedi vs. Henkel re Israel Trademark Number 242574, ruling on costs by Ms Yaara Shoshani -, 17 September 2014

 


Another patent restoration decision

October 17, 2014

Israel Patent Number 158968 to Ofer Dagan is titled “Solar water heater”. The application was filed on 20 November 2003 and the third renewal, covering years 10-14 should therefore have been paid by 20 November 2013, and with extension fees, by 20 May 2014. Applicant failed to pay these fees and the patent lapsed, with a notice of the patent lapsing being publishing in the July 2014 Journal.

The patentee signed a deal with a Cyprus based company that was supposed, inter alia, to maintain the patent. On 17 November 2013, the Cypriot company paid the fee for a filing a new patent application instead of the third renewal fee. Proof of payment, designating the patent number was appended to the request for reinstatement.

The Cypriot company turned to an Israeli company to maintain the patent and discovered the mistake. In the circumstances, the Deputy Commissioner Ms Jacqueline Bracha ruled that the circumstances fell within the ambit of section 60 of the Israel Patent Law, the difference in fees should be paid and the patent should be reinstated.

 


Israel Patent revived over seven years after it lapsed

October 16, 2014

carry on screaming   living dead

Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri was allowed on 11 July 2006, but the first renewal was never paid. Consequently as of 11 April 2007, the end of the six month grace period, it was considered as having lapsed as of 11 October 2006, and in the May 2007 a notice of the patent having lapsed published.

A mere seven years later on 21 May 2015, Yigal Tsabri, the patentee requested the patent be restored. In the request he detailed that around the time the patent issued his financial situation deteriorated and the connection between him and his agent of record was broken. The agent of record did not inform him of the requirement to pay the renewal fee and instead, opened a file with the government collection agency (Hozlap). On 19 December 2011 a bankruptcy order issued but the receiver had agreed to allow attempts to restore the patent.

On 25 May 2014 the Deputy Commissioner noted the long time that had passed and expressed concern that the case could not be considered reasonable. Although the applicant had described difficult circumstances he had not presented any evidence of having done anything to keep the patent alive. The applicant for restoration had not detailed when he learned that the patent had lapsed and why he’d needed a District Court authorization to file a request for restoration.

In the circumstances the Deputy Commissioner gave the Applicant an opportunity to appear before her on 22 June 2014. During this hearing it transpired that the lapsed patent was a source of income as it was being licensed! – this despite the fact the license was not registered with the Patent Office, the patent had lapsed as of October 2006 and apparently the licensee was unaware that the patent had lapsed! The income from the patent license was being used to pay off the bankruptcy debts.

The patentee declared that he’d learned about the patent lapsing about eight months prior to the request for restoration being filed. As soon as he’d learned of it lapsing he’d turned to the manager of the bankrupt estate (presumably the receiver – MF) and had got District Court Authorization to file the request for restoration as the fee for so doing came out of the bankruptcy estate.

The Applicant provided reasons from May 2006 until today, for not having been able to clarify the status of the patent which provides grounds for leniency, despite the patent being to some extent abandoned. These reasons were not published in the decision as they are of a personal nature.

The Court had apparently provided a public defender to represent the patentee, but he had failed to show up for the hearing so the patentee had represented himself.

The Deputy Commissioner ruled that the patent could be restored on payment of the various fees, but this decision publishes for opposition purposes. As the patentee is not represented, the decision is sent to him directly and also to the public attorney’s office.

Decision re restoration of 139892 to Yigal Tsabri. Ruling by Deputy Commissioner Ms Jacqueline Bracha, 9 September 2014.

COMMENTS

It does seem nice that a week and a half before Rosh Hashana, the Deputy Commissioner is showing clemency לפני משורת הדין.

However, 6 years is indeed a long time. It appears from the decision that the receiver had authorized the reinstatement back in 19 December 2011. From a first reading I assumed that this is one of the things that Ms Bracha wanted clarifying and is not actually the case. It also appears as if the patent attorneys had instituted the bankruptcy proceedings. Whilst this is certainly their right, I would be surprised if this is indeed the case. I also find it difficult to imagine that the agent of record didn’t forward the certificate. It seems more likely that they would warn regarding the first renewal and request all bills settled first.

The requirement for clarifying whether or not a patent is in force is to enter the Israel Patent Office website. The details are on line. The staff at the patent office are also fairly helpful over the phone. Indeed, if someone had come in to my office off the street wanting to know if a patent was in force, I would have told them , and suspect that this is true of many other patent offices.

The licensee has been paying money without minimal due diligence to check if there is a patent that is in force. This is surprising but not unbelievable.

Clients are odd things. I had a client who drafted his own application by copying someone else’s issued patent which he cited in the background. The basis of his claim to a patent was that he’d made the device smaller. Not surprisingly, the prior art was cited against him and that was when he came to me. I actually managed to make fairly drastic rewrites based on the figures and to obtain a patent. That inventor made the conscious decision to not to bother paying the first renewal fee since he was licensing the patent anyway!

I also had a Russian inventor who came to me with a portfolio of six patent applications, three of which had lapsed. He’d drafted the applications himself, and I suspect he’d written them in Russian and used a computer to translate the specification. I am always happy to take on a challenge, and managed to restore two of the cases that had lapsed within less than 12 months. I extensively rewrote the specifications without adding new material and got five of the six cases to issue. The earliest application had lapsed over three years earlier and I was unable to revive it, despite the applicant providing some evidence of periodic hospitalization and problems with a previous agent of record. He was unable to adequately demonstrate to the satisfaction of the Deputy Commissioner that he’d taken action promptly on first learning that the patent had lapsed, since I was taken on over a year later. It was a shame, since the patent was for a significant invention. The client wanted to appeal to the Courts, but did not instruct me on time. The Deputy Commissioner’s main concern was that third parties could have learned of the first application from a corresponding US case (published and allowed, however the issue fees were never paid). The rights of such third parties practicing the invention would have been compromised if the patent application was reinstated. I had actually tried to preempt this by offering an unconditional free license to any such third parties in the request for reinstatement itself. In the ruling refusing to all reinstatement, the issue of prejudicing unknown third parties and the need to strike a balance between the applicant’s rights and theirs was extensively discussed. My suggestion of an unconditional license wasn’t. Thisraised grounds for an Appeal to the Court, but the client didn’t instruct me on time and didn’t pay the fees. The main difference between that case and this is (a) that the Russian case was a lapsed application and this is a lapsed patent, and (b) specific health issues of each inventor, where the details of this case have not published. I jumped through all the legal hoops and related to every precedent to no avail. Presumably the patentee in this case did not, as he was unrepresented. What is interesting however, is that in the present case there is clearly a third-party who has not needed to pay licensing fees and was being defrauded, albeit possibly unintentionally. Now, by reinstating the patent, this actual and real licensee will have to continue paying fees hereinafter, possibly until November 2000. Go figure.

This ruling will publish for appeal purposes. The law granting the patent office discretion to revive long dead patents is clear. The question is whether the discretion was used wisely and whether the serious of events described by the patentee to justify the revival were true. We do not know what they are. The decision as published is heavily censored to protect the patentee’s privacy. Unless third parties can access the details, how can they challenge them? Can the former agents of record produce evidence against their ex-client who apparently did not settle his bills, to show that he did receive details of the deadline for renewal? Would this be a considered unethical? What about the hapless licensee who has being paying royalties to use a lapsed patent? It is unlikely that someone not involved would oppose a case with virtually no chance of recovering costs as the patentee is apparently bankrupt.


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